Inês Ribeiro Vaz is an integrated researcher at CINTESIS – Center for Health Technology and Services Research, the coordinator of the technical team of the Porto Pharmacovigilance Unit, based at the Faculty of Medicine of the University of Porto (FMUP), where she has been teaching for several years. Since January, she is also the national representative of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), appointed by the INFARMED – Portuguese National Agency of Medicines and Health Products.

She was born in June 1975 in Porto, after her parents who are originally from Viseu, settled there. She studied from 5th to 12th grade at the Cerco School, which is to this day, highly stigmatized because of its proximity to a social housing estate neighborhood. “The reputation is unfair,” she says. “I really liked studying there. I only have good memories and great friends from that time.”

The researcher fell in love with chemistry in 10th grade. When a teacher told her about the Pharmacy study program, “it clicked.” She ended up entering the Faculty of Pharmacy at the University of Porto in 1993, as her first choice. “I had the grades to get in wherever program I wanted. It was almost a scandal that I didn’t choose Medicine [laughs]. But Chemistry was what I was passionate about. I just didn’t want to work in a community pharmacy,” she explains.

When Inês Ribeiro Vaz finished her degree in 1999, she was invited to develop a project in the area of manipulated medicines, at the Portuguese National Association of Pharmacies (ANF). In 2003, she joined the Pharmacovigilance Unit of Porto (then called “Northern Pharmacovigilance Unit”). The Unit had been set up a few years earlier at FMUP, under the coordination of Altamiro da Costa Pereira and Jorge Polónia, who still works as a coordinator.

“I realized it was what I wanted to do. It’s an area that I love. I don’t have a job; I have a mission. My mission is to make medicines safer. That mission starts the day a medicine hits the market and it’s constant. It never ends. The main challenge has always been to combat the underreporting of adverse drug reactions (ADRs). That is why it is important to talk to health professionals. My obligation is to make their lives easier. That has always been my vision,” she stresses.

In addition to her usual work, she has always carried out research. She completed her Master’s in Public Health at FMUP in 2009. She developed active measures to combat the underreporting of adverse drug reactions and she realized that direct contact with health professionals immediately resulted in a large increase in notifications. Simple measures such as placing hyperlinks on the desktop of hospital healthcare professionals’ computers with access to the online notification form can make all the difference.

She completed the PhD in Clinical and Health Services Research (PDICSS) atFMUP in 2016. The major milestone of her Ph.D. was the creation of her own system at the Local Health Unit of Matosinhos (ULSM). “SIRAI – Adverse Reactions and Incidents Information System is a database made from scratch for Pharmacovigilance, allowing the hospital to store information and do its own risk management for patient safety. I think this system can be a prototype for other hospitals”, she considers.

She joined CINTESIS in the early 2010s and is currently part of theHIS-EHR: Sistemas de Informação em Saúde e Registos de Saúde Eletrónicos group, led by Ricardo Cruz Correia. “I realized that IT tools can be allies of Pharmacovigilance, both as a source of information and to facilitate notifications. One of the things we did was to connect a clinical record to the Unit’s database, through a webservice. All health professionals must do is to press a button and the Unit receives the information, which avoids duplication of effort and the loss of fundamental data,” she indicates, adding that the INFARMED has meanwhile adopted this same strategy at a national level. The technology was implemented jointly with VirtualCare, a spin-off of CINTESIS/FMUP and the U.Porto and GEDII – Study Group of Inflammatory Bowel Disease.

In recent years, her research work has been inevitably marked by the pandemic. “At the beginning of the pandemic, no one really knew how to treat the disease. We knew the benefit and risk of medicines in the pathologies for which they were developed, but we didn’t know their benefit in COVID-19,” she recalls.

Interestingly, the pandemic finally revealed to the public the importance of ADR reporting. “All of a sudden, in 2021, we had four COVID-19 vaccines on the market, and everyone got to know they could report their suspected ADR. We had a 10-fold increase in reporting. People reported anything and everything. It was also our fault, the academia and the authorities. We were not able to communicate properly. Suspending a vaccine that caused thromboembolic events as a precaution was a mistake. Oral contraceptives cause more events and were never suspended as a precaution. We have a lot to learn from what happened,” she emphasizes.

Together with other researchers from CINTESIS/FMUP, Inês Vaz recently published a review of the safety profile of various drugs used in COVID-19 (even those not approved for the disease), such as hydroxychloroquine, remdesivir, ivermectin, based on studies conducted worldwide. The aim is for the review to be a clinical decision support document.

1-Year Ambition

We are part of three European consortia of studies currently underway, two of which are on COVID-19. One of these studies aims to analyze the safety profile of vaccines in certain groups of people vaccinated against SARS-CoV-2, namely in pregnant and breastfeeding women, immunocompromised patients, and children, through questionnaires applied in several countries, including Portugal. The results should be known next year.

In another consortium, we are studying the impact of communication on so-called blood clots (thromboembolic syndrome with thrombocytopenia) in the COVID-19 vaccination campaign through questionnaires to healthcare professionals and the general population. The study, requested by the European Medicines Agency (EMA), is being conducted in six European countries and is led by the Utrecht University. The results should also be known in 2023.

The third consortium aims to understand whether ADR risk minimization measures should be included in the clinical guidelines that doctors have for the treatment of diseases.

10-Year Ambition

I intend to keep the UFPorto as a reference Unit at a national level. As the national representative of the Pharmacovigilance Risk Assessment Committee (PRAC) of theEuropean Medicines Agency (EMA), I hope to bring our regional vision to the EMA and vice-versa.

I want Pharmacovigilance to be ever closer to people. Our work, besides being scientific, is about providing a service to the community. We are here to make medicines safer.

In terms of research, I am very interested in studying the impact of drug risk minimization measures on certain populations. In the long term, it seems to me that I will continue with this research because it will be increasingly necessary.

Life Beyond Research

I don’t have a lot of spare time. I love reading. I love fiction, and South American literature. I also love Brazilian culture, I’m fascinated, above all, by Brazilian music. My great passion is Rio de Janeiro, and in my adolescence, my dream was to go there. When I started working, I saved up some money, took a holiday, and spent a month there, alone.

I really like cinema and going to concerts. I was part of an amateur choir of parents and caretakers at the Conservatory of Porto, where my daughter was studying, until the start of the pandemic. I also really like going to the beach. I used to go diving, but when my daughter was born 16 years ago, I stopped.

In the future, I want to travel, I want to go back to Rio de Janeiro. I’ve been there four times, for leisure. It’s a passion, I don’t want to get married, I always want to be in love.